FDA Releases New Sunscreen Regulations

Yesterday the U.S. FDA, Food and Drug Administration, released its new sunscreen regulations after 33 years of deliberation. They announced “that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn.” You can access the full press release here. These new regulations will become effective in one year. Manufacturers with an annual sales less than $25,000 will have two years to comply.

It does seem a long time coming and this is just the beginning! Sunscreen regulations, safety and manufacturer responsibility can only get better (hopefully it won’t take another 33 years). Not everyone thinks that the U.S. FDA is making strides. The EWG believes that some of the FDA’s regulations have fallen short of what is needed for the public to make safe healthy choices from the sunscreens on the U.S. market. In their own press release the Environmental Working Group expresses their dissatisfaction. They feel like the new regulations are too ambiguous and not strict enough. Which could allow at least 20% of products sold in the U.S. to be sold even though they don’t provide the right amount of UVA protection.

You can make your own mind up about the new regulations. Feel free to leave a comment or join the discussion on the UV Skinz Facebook fan page! Let’s take a look at the new regulations…

The FDA new rules state that manufacturers of sunscreen products may not use misleading claims.

A bar on these terms:

“waterproof”

“sweatproof”

“sunblock”

The final regulation allows sunscreen products that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as “Broad Spectrum.”

Only sunscreens labeled “Broad Spectrum” with an SPF of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.

Sunscreens that are not “Broad Spectrum” or are “Broad Spectrum” with an SPF values between 2-14 will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

The U.S. FDA also added three regulatory documents to the final rule for the sunscreen regulations.

The Proposed Rule would limit the maximum SPF on a product to “50+” because there isn’t any data supporting that any higher of SPF is more effective.

The ANPR (Advance Notice of Proposed Rulemaking) will give the public a chance to speak out and submit data or suggestions about the safety of sunscreen sprays.

The Draft Enforcement Guidance for Industry will give manufacturers an outline on how to label and test their products to meet the new regulations.

FDA will reexamine but no changes to active ingredients; oxybenzone or retinyl palmitate.

The ingredients in sunscreens marketed today have been used for many years and FDA does not have any reason to believe these products are not safe for consumer use.

This last statement is another reason that (I) and the EWG feel like the FDA fell short on making regulations with the public safety and trust in the U.S. market in mind. In no way does this final rule give any concern to the toxicity of the chemicals used by people all across the United States. I hope in the future the FDA changes its sunscreen regulations to include a warning label about the toxicity of the main ingredients in chemical sunscreen.

What did you agree or disagree with? Do you feel like this is a step in the right direction? What more could be done?